BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIP SZ. 30 PROXIMAL

    MDR report key: 11047246 · Received December 21, 2020

    Report

    Report Number
    1651501-2020-00024
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Report Date
    April 20, 2021
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    OMX
    PMA / PMN Number
    H010005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION: DHR: A REVIEW OF THE LOT RECORDS WAS CONDUCTED AND THERE WERE NO INDICATIONS OF PROBLEMS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT. FAILURE ANALYSIS: VISUAL EXAMINATION OF THE PART FOUND THAT THE HEAD WAS BROKEN FROM THE STEM OF THE IMPLANT. THE FAILURE WAS CONFIRMED. ROOT CAUSE: VISUAL EXAMINATION OF THE PART DETERMINED THAT THE POTENTIAL CAUSES IDENTIFIED FOR SIMILAR INTRAOPERATIVE PIP FRACTURES (IMPROPERLY PREPARED OBLIQUE OSTEOTOMY, IMPROPER PLACEMENT OF THE IMPLANT (E.G., IMPACTING UNSUPPORTED HEAD WITH TOO MUCH FORCE), OR IMPROPER IMPLANT SIZE SELECTION) LIKELY CONTRIBUTED TO THIS INCIDENT.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). THE PERFORATOR WAS NOT RETURNED FOR EVALUATION, THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED, THEREFORE, MANUFACTURING RECORDS WERE REVIEWED, AND FOUND NO ANOMALIES. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THE PIP PROXIMAL IMPLANT BROKE WHEN IT WAS BEING INSERTED INTO THE PATIENT. ALL BROKEN PARTS WERE RETRIEVED, AND THE EVENT LED TO 45 MINUTES SURGICAL DELAY WITH NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514245 PIP SZ. 30 PROXIMAL PIP OMX ASCENSION ORTHOPEDICS 185169T

    Patients

    Seq Age Sex Outcome Treatment
    1